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EBIS for Suicide Prevention Anxiety

N/A

Recruiting

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of trial period (12 weeks)

Awards & highlights

Study Summary

This trial will develop & pilot test a strategy to help mental health clinicians screen, assess, & intervene with patients at risk for suicide. 15 clinicians partner in the development & 40 in a pilot clinical trial with either usual or enhanced implementation.

Who is the study for?

This trial is for practicing mental health clinicians who work directly with patients seeking treatment. They must be proficient in English and have internet access to participate.Check my eligibility

What is being tested?

The study tests a new strategy called EBIS aimed at reducing clinician anxiety around suicide prevention, compared to the usual implementation methods. Clinicians will be randomly assigned to one of these two approaches.See study design

What are the potential side effects?

Since this trial involves training strategies rather than medical treatments, traditional side effects are not applicable. However, participants may experience stress or discomfort related to discussing suicide prevention.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of trial period (12 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of trial period (12 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of trial period (12 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinician perception of EBIS acceptability for clinical practice

Clinician perception of EBIS feasibility and utility for clinical practice

EBIS feasibility as assessed by clinician retention statistics

Secondary outcome measures

Clinician Anxiety

Clinician Self-Efficacy Questionnaire

Safety Planning Intervention Use

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Exposure Based Implementation Strategy (EBIS)Experimental Treatment1 Intervention

EBIS is informed by the latest science in exposure theory, borrowing heavily from brief exposure-based treatments that can be delivered in a single session. We anticipate that EBIS will occur in four phases that map on to standard exposure therapy practice for patients with anxiety disorders: psychoeducation, assessment, practice, and relapse prevention; however, the final version will depend on the outcomes of the preparatory phases of this study. Clinicians assigned to the EBIS arm will also receive all elements of IAU.

Group II: Implementation as Usual (IAU)Active Control1 Intervention

Gold-standard IAU for SSAIs typically comprises pre-implementation preparation, didactic training, knowledge tests, experiential role plays, ongoing expert consultation, and providing certification status to clinicians who attain established benchmarks. Pre-implementation preparation will include provision of materials. Didactic training will occur in two parts: (1) suicide screening and assessment, and (2) Safety Planning Intervention (SPI) use. Part one will consist of materials we previously developed based on community clinician feedback. Part two will follow established SPI guidelines, including didactic training about SPI rationale and evidence base and experiential practice. IAU also will include supports for electronic health record integration (e.g., previously developed templates). After training, clinicians will receive 8 weeks of expert consultation to discuss implementation barriers and receive more role play practice.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,005 Previous Clinical Trials

42,882,178 Total Patients Enrolled

2 Trials studying Implementation Science

3,086 Patients Enrolled for Implementation Science

Media Library

Exposure Based Implementation Strategy (EBIS) Clinical Trial Eligibility Overview. Trial Name: NCT05172609 — N/A

Implementation Science Research Study Groups: Implementation as Usual (IAU), Exposure Based Implementation Strategy (EBIS)

Implementation Science Clinical Trial 2023: Exposure Based Implementation Strategy (EBIS) Highlights & Side Effects. Trial Name: NCT05172609 — N/A

Exposure Based Implementation Strategy (EBIS) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05172609 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent has this trial been populated with participants?

"Affirmative. According to clinicaltrials.gov, this experiment has been available since March 29th 2023 and is presently recruiting participants across 1 location. To reach their goal, 55 patients are needed in total."

Answered by AI

Are there any vacant slots remaining in this research trial?

"Affirmative. According to the clinicaltrials.gov page, this research is currently recruiting participants who meet their criteria. The trial was commenced on March 29th 2023 and updated most recently on May 8th of that same year; 55 individuals are needed from a single site for full completion."

Answered by AI

What are the projected results of this medical research?

"The primary endpoint of this trial, measured over a 12 week time frame, will be the clinician's acceptance rate of EBIS in real-world practice. Secondary outcomes encompass Clinician Self-Efficacy Questionnaire scores (1 to 7 range), screening use as assessed via Chart Stimulated Recall and Safety Planning Intervention Use also determined through Chart Stimulated Recall."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Exposure-Based Implementation Strategy to Decrease Clinician Anxiety Around Suicide Prevention

2023. "An Exposure-Based Implementation Strategy to Decrease Clinician Anxiety Around Suicide Prevention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05172609.